Note: Descriptions are shown in the official language in which they were submitted.
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PROSTHETIC IMPLANTS HAVING SHELLS WITH FLEXIBLE NEEDLE
STOP PATCHES MADE OF TWO OR MORE LAYERS OF TEXTILE MATERIAL
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] The present patent application claims benefit of U.S. Provisional
Application Ser. No.
63/234,848, filed on August 19, 2022, the disclosure of which is hereby
incorporated by reference
herein.
BACKGROUND OF THE INVENTION
Field of the Invention
[0002] The present patent application is generally related to implantable
prosthetic implants
such as breast implants and tissue expanders and is more specifically related
to needle stops
and needle guards that are incorporated into the shells of tissue expanders.
Description of the Related Art
[0003] Tissue expanders are devices that are implanted beneath the skin or
muscle and then
gradually inflated with fluid to stretch the overlying tissue. Tissue
expanders are typically used to
either create a pocket for receiving a permanent prosthesis, or to generate an
increased skin
surface area in anticipation of the new skin being utilized for grafting or
reconstruction.
[0004] Tissue expanders are typically formed of a silicone polymer shell.
After implantation,
a fluid, such as saline, is periodically injected into the tissue expander to
enlarge it over time.
Between injections, the surrounding skin is permitted to stretch and grow to
create the increased
skin surface and the increased tissue pocket for receipt of a permanent
implant.
[0005] A tissue expander can be provided with an injection port (e.g., a
port comprising a
septum) that can be pierced with a hypodermic needle for introducing fluid
into the expander. It
can be difficult, however, to accurately locate the injection port through the
overlying tissue. If the
injection port is missed and the needle punctures the shell of the tissue
expander, the expander
can leak. Most often, this requires the expander to be removed and replaced.
This problem can
be addressed by providing an injection port flint is rAmote from the tissue
expander but that is in
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fluid communication with the expander. Such systems are described in U.S.
Patent No.
4,190,040.
[0006] Other solutions include eliminating the need for an injection site
altogether by forming
the expander with a self-sealing shell that can be pierced with a hypodermic
needle at any point
for the purpose of adding fluid to the shell. For example, U.S. Patent No.
5,066,303 discloses a
tissue expander formed using a self-sealing shell material that reportedly can
be safely pierced in
any location.
[0007] U.S. Patent No. 6,743,254 to Guest et al., assigned to Mentor
Corporation, the
disclosure of which is hereby incorporate by reference herein, teaches a
tissue expander that
contains a self-sealing area that surrounds an injection port. The self-
sealing area reduces the
risk of causing a leak in the expander when a hypodermic needle that is used
to fill the expander
misses the injection port, thereby reducing the frequency with which expanders
require removal
due to leakage caused by inadvertent punctures.
[0008] Tissue expanders may incorporate flexible needle stops that enable
the tissue
expander to be folded for insertion into a patient. For example, U.S. Patent
No. 4,908,029 to Bark
et al. discloses a flexible needle stop that includes a normally unfolded an
impenetrable needle
barrier formed of a flexible foldable material. The flexible foldable material
can be a single layer
sheet material, a wire mesh material and/or one or more layers of scale-like
components arranged
side by side. The scale-like components are physically unconnected and of a
size that permits
flexion of the needle stop. The flexible needle stop can include a bead-like
periphery, which
affords the needle stop with a resilient memory and helps restore the needle
stop member to its
normally unfolded condition after a folding restraint is removed. The needle
stop can be freely
disposed within a fill chamber of a tissue expander, attached to an inner
surface of the fill
chamber, or incorporated in the shell wall of a tissue expander.
[0009] U.S. Patent Application Publication No. 2016/0074152 to Chitre et
al. discloses a
method of making a needle guard for an inflatable prosthesis suitable for
implantation in a
mammal. The method includes the steps of providing a first layer of puncture
resistant members,
for example, elongated slats, providing a second layer of puncture resistant
members such that
the second layer of members overlies and is rIffcglt from the first layer of
members, and molding
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or otherwise applying a flexible material to the first layer of members and
the second layer of slats
to form a device useful as a needle guard for an inflatable prosthesis. The
step of applying or
molding includes coupling the members to (e.g., encasing the members within)
the flexible
material.
[0010] Materials are often evaluated to determine their suitability for
being used to make
needle stops. FIGS. 1 and 2 show a prior art system 50 that is configured for
testing materials
that are used to make needle stops for prosthetic devices. The system 50 tests
the materials to
ensure that the needles used to fill prosthetic implants will fail (e.g., by
bending) before the
material utilized to make the needle stop fails. The testing system 50
includes an lnstron machine
52 that holds a needle 54. The lntron machine 52 moves the needle 54 up and
down along a
vertical axis Al so that a sharpened needle tip at a lower end of the needle
engages the materials
that are being evaluated.
[0011] The testing system 50 includes a fixture plate 56 that holds the
material 58 that is being
evaluated. Pursuant to standard ASTM 1441-03, the needle 54 must fail against
the material 58
before the material fails. According to the ASTM 1441-03 standard, during
testing, a 21-gauge
needle having a length of 1.5 inches is utilized. The Instron machine 52
applies a downward force
on the needle 54 against the material 58, and the 21-gauge needle breaks at
approximately 6.5
pounds per foot. Therefore, for the material 58 to satisfy the ASTM 1441-03
standards and be fit
to serve as an effective needle stop barrier, the material 58 must prevent
needle penetration for
forces of greater than 6.5 pounds per foot. If the needle 54 penetrates
through the material 58
before the needle fails (e.g., bends), then the material 58 has not met the
ASTM 1441-03 standard
and cannot be used to make an effective needle guard.
[0012] Referring to FIG. 3, when certain materials (e.g., metal sheets) are
used to make
needle stops, the sharpened needle tip 60 of the needle 54 (FIG. 2) may become
damaged. In
FIG. 3, the sharpened needle tip 60 is damaged and is bent into a fishhook
shaped configuration.
In addition, lateral surfaces within a tapered region 62 of the needle 54 are
also damaged.
[0013] In prosthetic implants with self-sealing shells, needles are passed
through the shell
and advanced into an interior chamber of the shell to fill the prosthetic
implant with a filler material
(e.g., gel; saline solution). If the prosthe+ie imnlent has a conventional
needle guard, the
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sharpened tip of the needle may be damaged (e.g., bent into a fishhook shape)
if it is pressed
against the needle guard. When the damaged needle is later withdrawn from the
shell (e.g., after
the shell is filled), the damaged tip of the needle may tear or puncture the
shell, which may cause
catastrophic damage to the shell, including shells meant to self-seal after
needle withdrawal.
[0014] Referring to FIG. 4, when the damaged needle 54 shown in FIG. 3 is
withdrawn from
the shell 64 of a prosthetic device, the fishhook-shaped tip 60 is likely to
for a tear 66 or puncture
in the shell 64. The tear 66, created by the fishhook-shaped tip 60 of the
damaged needle 54 will
allow the filling material 68 that fills the inside of the shell 64 to flow
out of the tear 66. Thus,
catastrophic damage to the shell 64 of a prosthetic device may result when a
damaged needle is
withdrawn from a shell after filling the shell with a gel or a saline
solution.
[0015] In view of the above deficiencies in the prior art, there is a need
for providing a
prosthetic implant with a needle stop that can resist greater than 6.5 pounds
of force (in the case
of a 21-G needle), while minimizing needle tip damage that could result in a
failure of the shell of
an implant.
SUMMARY OF THE INVENTION
[00161 Conventional breast tissue expanders typically incorporate an
integrated injection
port. Though the injection port provides an important functionality, namely
the ability to
inflate and deflate of the tissue expander via percutaneous puncture with a
needle, it also
adds bulk to the tissue expander, resulting in reduced flexibility when
folding and inserting
the expander into the breast pocket and potentially increased patient
discomfort and
palpability.
(0017] In one embodiment, a construction for a needle stop patch is
disclosed that
minimizes needle tip damage, which may result in shell tearing and damage that
normally
would not be prevented from self-sealing shell constructs. The prior art
includes numerous
disclosures of self-sealing elastomeric shell membranes, which address self-
sealing when
penetrated with normal needles but do not account for the withdrawal of a
potentially
damaged needle tip. The needle stop patch disclosed herein improves upon the
prior art
by reducing the potential of needle deformation, which may result in shell
tearing and leaks.
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[0018] In one embodiment, the needle stop patch provides an impenetrable
posterior
backing that provides numerous improvements over the prior art.
[0019] First, the needle stop patch disclosed herein is impenetrable to
needle puncture
up to a specified gauge size (i.e., the needle must fail without penetrating
through the
needle stop patch).
[0020] In one embodiment, the needle stop patch is flexible (i.e., low
bending stiffness)
so that it can be easily folded and inserted into a breast pocket.
[0021] In one embodiment, the needle stop patch has a sufficient thickness
and has an
open communication to the internal lumen of the shell so that when a needle is
pressed
against the needle stop patch, the needle hole is not occluded, and the
expander can be
inflated even if it is in an initially collapsed/empty state.
[0022] In one embodiment, the needle stop patch is constructed so that it
stops the
needle from penetrating while minimizing the damage to the needle tip. In
traditional
expander injection ports, when needles are pressed against the port stop, it
is possible to
cause the tip of the needle to be damaged into a "fish-hook" shape. This is
typically mitigated
with the use of a more flexible polymeric dampening layer on the stop, but tip
damage is still
possible given the rigid nature of the stop. The needle stop patch disclosed
herein is made
of multiple layers of a textile material. One or more of the layers may
include elastomeric
sheeting. The layers of the textile material result in large frictional forces
on the needle so
that the penetration force is broadly distributed on the needle rather than
localizing at the
tip.
[0023] As used herein, the term textile material means a flexible material
made by creating
an interlocking network of threads, which are produced by spinning raw fibers
from either natural
or synthetic sources into long and twisted lengths. Textiles may be formed by
weaving, knitting,
crocheting, knotting, tatting, felting, bonding or braiding the threads
together.
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[0024] In one embodiment, a self-sealing shell membrane self-seals when
punctured with
a needle up to a specified gauge size. In one embodiment, a self-sealing
tissue expander is
disclosed that eliminates the need for a port by incorporating a self-sealing
shell.
[0025] In one embodiment, a prosthetic implant, such as a tissue expander,
preferably
includes a silicone shell having an anterior wall and a posterior wall, and a
needle stop patch
secured over an inner surface of the posterior wall of the silicone shell.
(0026] In one embodiment, the needle stop patch may include two or more
layers of a textile
material (e.g., 4-10 layers) that are stacked atop one another to form a multi-
layer structure.
[0027] In one embodiment, a bonding material is used for bonding together
the two or more
layers of the textile material that are stacked atop one another.
[0028] In one embodiment, the textile material may include natural or
synthetic threads or
fibers that are woven together to form a layer for a needle stop patch.
[0029] In one embodiment, the bonding material (e.g., curable silicone
material) preferably
passes through the two or more layers of the textile material for bonding the
layers together.
[0030] In one embodiment, each of the two or more layers has an outer edge
that defines an
outer perimeter. In one embodiment, only the outer perimeters of the two or
more layers are
bonded together.
[0031] In one embodiment, the layers have different sizes. In one
embodiment, the outer
perimeter of a top layer of the two or more layers defines a first area and
the outer perimeter of a
bottom layer of the two or more layers defines a second area that is larger
than the first area of
the top layer.
[0032] In one embodiment, the outer perimeter of an intermediate layer of
the two or more
layers, which is between the top layer and the bottom layer, defines an
intermediate area that is
larger than the first area of the top layer and smaller than the second area
of the bottom layer.
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[0033] In one embodiment, the respective outer edges of the two or more
layers are feathered
for minimizing step effects between adjacent ones of the two or more layers.
[0034] In one embodiment, the bonding material may secure the needle stop
patch to the
posterior wall of the silicone shell.
[0035] In one embodiment, wherein each of the two or more layers of the
textile material has
a circular or oval shape.
[0036] In one embodiment, the bonding material has a ring shape that
matches the circular
or oval shape of each of the two or more layers of the textile material.
[0037] In one embodiment, at least one of the two or more layers of the
textile material is
laminated in elastomeric sheeting.
[0038] In one embodiment, the anterior wall of the silicone shell may
include a self-sealing
membrane.
[0039] In one embodiment, the self-sealing membrane may include a three-
layer construction
having a middle layer of an elastomeric material having first and second major
surfaces, a first
outer layer of an elastomeric material overlying the first major surface of
the middle layer, and a
second outer layer of an elastomeric material overlying the second major
surface of the middle
layer, whereby the middle layer of the elastomeric material holds the first
and second outer layers
of the elastomeric material in contraction.
[0040] In one embodiment, each layer of the two or more layers of the
textile material has a
top surface, a bottom surface and a plurality of holes that extend from the
top surface to the
bottom surface.
[0041] In one embodiment, a needle may be used for filling the silicone
shell with a fluid (e.g.,
a gel: a saline solution). In one embodiment the needle has a cross-sectional
area and a total
combined area of the plurality of the holes for each layer is preferably
greater than the cross-
sectional area of the needle.
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[0042] In one embodiment, the denier count of the two or more layers of the
needle stop patch
progressively increases from a top layer to a bottom layer of the patch for
providing the needle
stop patch with a progressively increasing resistance level from the top layer
to the bottom layer.
[0043] In one embodiment, a top layer of the two or more layers of the
textile material has a
first denier count and a bottom layer of the two or more layers of the textile
material has a second
denier count that is greater than the first denier count of the top layer.
[0044] In one embodiment, a prosthetic implant preferably includes a
silicone shell having an
anterior wall and a posterior wall, and a needle stop patch secured over an
inner surface of the
posterior wall of the silicone shell.
[0045] In one embodiment, the needle stop patch preferably includes a
plurality of layers of a
textile material that are stacked atop one another, and a bonding material for
joining together the
plurality of layers of the textile material that are stacked atop of another.
[0046] In one embodiment, a self-sealing membrane may be integrated into
the anterior wall
of the silicone shell.
[0047] In one embodiment, the self-sealing membrane desirably includes a
middle layer of
an elastomeric material having first and second major surfaces, a first outer
layer of an
elastomeric material overlying the first major surface of the middle layer,
and a second outer layer
of an elastomeric material overlying the second major surface of the middle
layer, whereby the
middle layer of the elastomeric material holds the first and second outer
layers of the elastomeric
material in contraction.
[0048] In one embodiment, an outer surface of the first outer layer of the
elastomeric material
is secured to an inner surface of the anterior wall of the silicone shell.
[0049] In one embodiment, a top layer of the plurality of the layers has an
outer edge defining
a first area and a bottom layer of the plurality of layers has an outer edge
defining a second area
that is larger than the first area of the top layer.
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[0050] In one embodiment, an intermediate layer of the plurality of layers,
which is located
between the top layer and the bottom layer, preferably has an outer edge that
defines an
intermediate area that is larger than the first area of the top layer and
smaller than the second
area of the bottom layer.
[0051] In one embodiment, the respective outer edges of each of the
plurality of layers are
desirably feathered for minimizing step effects between adjacent ones of the
plurality of layers.
[0052] In one embodiment, each layer of the plurality of layers of the
textile material has a top
surface, a bottom surface and a plurality of holes that extend from the top
surface to the bottom
surface.
[0053] In one embodiment, a needle may be used for filling the silicone
shell with a fluid. In
one embodiment, the needle has a cross-sectional area and a total combined
area of the plurality
of holes for each layer is preferably greater than the cross-sectional area of
the needle.
[0054] In one embodiment, the denier count of each layer of a needle stop
patch
progressively increases from the top layer to the bottom layer for
progressively increasing
resistance levels within the needle stop patch.
[0055] In one embodiment, the top layer of the plurality of layers of the
textile material has a
first denier count and the bottom layer of the plurality of layers of the
textile material has a second
denier count that is greater than the first denier count of the top layer.
[0056] In one embodiment, a method of making a multi-layer needle stop
patch for a silicone
shell preferably includes obtaining a first layer of a textile material, the
first layer having an outer
edge that defines a first area for the first layer and centering a second
layer of a textile material
over the first layer, the second layer having an outer edge that defines a
second area for the
second layer that is less than the first area for the first layer.
[0057] In one embodiment, the method preferably includes centering a third
layer of a textile
material over the second layer, the third layer having an outer edge that
defines a third area for
the third layer that is less than the second area for the second layer.
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[0058] In one embodiment, the method preferably includes centering a fourth
layer of a textile
material over the third layer, the fourth layer having an outer edge that
defines a fourth area for
the fourth layer that is less than the third area for the third layer.
[0059] In one embodiment, the method includes bonding the respective outer
edges of the
first, second, third and fourth layers together to form a multi-layer stack.
[0060] In one embodiment, the respective outer edges of the layers are
feathered for reducing
step effects between the first, second, third and fourth layers.
[0061] In one embodiment, the method includes providing a silicone shell
having an anterior
wall and a posterior wall and securing the first layer of the multi-layer
needle stop patch to an
inner surface of the posterior wall of the silicone shell.
(0062] In one embodiment, each layer may include a plurality of holes
extending from a top
surface to a bottom surface thereof.
[0063] In one embodiment, the first layer of a textile material has a first
denier count, the
second layer of a textile material has a second denier count that is less than
the first denier count,
the third layer of a textile material has a third denier count that is less
than the second denier
count, and the fourth layer of a textile material has a fourth denier count
that is less than the third
denier count.
(0064] In one embodiment, at least one of the layers of a textile material
is laminated in
elastomeric sheeting.
[0065] These and other preferred embodiments of the present patent
application will be
described in more detail herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0066] FIG. 1 is a schematic view of a prior art system used for testing a
needle stop.
[0067] FIG. 2 is a perspective view a prior art system used for testing a
needle stop.
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[0068] FIG. 3 is a perspective view of a prior art needle that is damaged
and that has a bent
needle tip.
[0069] FIG. 4 is a perspective view of a prior art prosthetic implant
having an outer shell with
a puncture and filling material leaking through the puncture.
[0070] FIG. 5 is a cross-sectional view of a prosthetic implant have a self-
sealing shell and a
needle stop patch covering a posterior wall of the seal-sealing shell, in
accordance with one
embodiment of the present patent application.
[0071] FIG. 6 is a schematic cross-sectional view of the self-sealing shell
of the prosthetic
implant shown in FIG. 5, in accordance with one embodiment of the present
patent application.
[0072] FIG. 7 is a schematic cross-sectional view of the needle stop patch
shown in FIG. 5,
in accordance with one embodiment of the present patent application.
[0073] FIG. 8 is a cross-sectional view of a needle stop patch that covers
a posterior wall of
a shell of a prosthetic implant, in accordance with one embodiment of the
present patent
application.
[0074] FIG. 9A shows a first stage of a method of making a needle stop
patch, in accordance
with one embodiment of the present application.
[0075] FIG. 9B shows a second stage of a method of making a needle stop
patch, in
accordance with one embodiment of the present patent application.
[0076] FIG. 90 shows a third stage of a method of making a needle stop
patch, in accordance
with one embodiment of the present patent application.
[0077] FIG. 9D shows a fourth stage of a method of making a needle stop
patch, in
accordance with one embodiment of the present patent application.
[0078] FIG. 10A is a top view of the assembly shown in FIG. 9A.
[0079] FIG. 10B is a top view of the assembly shown in FIG. 9B.
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(0080] FIG. 100 is a top view of the assembly shown in FIG. 90.
(0081] FIG. 10D is a top view of the assembly shown in FIG. 9A.
(0082] FIG. 11 shows a top view of a first textile layer of a needle stop
patch and a cross-
sectional view of a needle, in accordance with one embodiment of the present
patent application.
(0083] FIG. 12 shows a top view of the first textile layer of FIG. 11 and a
second textile layer
that is assembled with the first textile layer to make a needle stop patch, in
accordance with one
embodiment of the present patent application.
[0084] FIG. 13 is a cross-sectional view of the first and second textile
layers of FIG. 12 after
the second textile layer has been assembled over the first textile layer.
(0085] FIG. 14 is a cross-sectional view of a needle stop patch for a shell
of a prosthetic
implant, in accordance with one embodiment of the present patent application.
[0086] FIG. 15 is a graph of the force required to penetrate needle stop
patches made of
different materials and having a different number of layers to show the
penetration resistance of
the different needle stop patches.
[0087] FIG. 16 shows a prior art method of testing the stiffness of a
textile material to
determine its suitability for use in a needle stop patch, in accordance with
one
embodiment of the present patent application.
[0088] FIG. 17 is a graph that shows the flexibility of needle stop patches
having
different designs and how the flexibility changes in response to the number of
textile
layers added to a needle stop patch, in accordance with one embodiment of the
present
patent application.
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DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0089] Referring to FIG. 5, in one embodiment, a prosthetic implant 100
(e.g., a tissue
expander) preferably includes a shell 102 (e.g., a silicone shell) having an
interior chamber 104
that may be filled with a fluid such as saline to expand the size of the
shell. In one embodiment,
the shell 102 may be made of a self-sealing membrane such as the self-sealing
membranes
disclosed in commonly assigned U.S. Provisional Application No. 63/157,285,
filed on March 5,
2021, the disclosure of which is hereby incorporated by reference herein. In
one embodiment,
the shell 102 preferably has a posterior wall 105 that is covered by a needle
stop patch 106
comprising one or more layers of a textile material, also referred to herein
as textile layers.
[0090] Referring to FIG. 6, in one embodiment, the self-sealing shell
membrane 102 (FIG. 5),
such as the self-sealing membranes disclosed in commonly assigned U.S.
Provisional Application
No. 63/157,285, filed on March 5, 2021, the disclosure of which is hereby
incorporated by
reference herein, may have three layers including an intermediate layer 108 of
a silicone
elastorner, and first and second outer layers 110A, 110B of a silicone
elastomer that are held in
contraction by the intermediate layer 108.
[0091] Referring to FIG. 7, in one embodiment, the needle stop patch 106
(FIG. 5) preferably
includes one or more layers of textile material. In one embodiment, the needle
stop patch 106
preferably includes one or more layers of textile material that are joined
together to form the
needle stop patch. In one embodiment, the needle stop patch 106 preferably
includes a first
textile layer 112 including interwoven threads 114A-1140. The first textile
layer 112 may be
laminated or imbedded in a first layer 115 of a polymeric material.
[0092] In one embodiment, the needle stop patch 106 desirably includes a
second textile
layer 116 including a plurality of interwoven threads 118A-118C that are free
to move relative to
one another.
[0093] In one embodiment, the needle stop patch 106 preferably includes a
third textile layer
120 having a plurality of interwoven threads 122A-122C that are free to move
relative to one
another.
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[0094] In one embodiment, the needle stop patch 106 preferably includes a
fourth textile layer
124 having a plurality of interwoven threads 126A-126C that are free to move
relative to one
another.
[0095] In one embodiment, the second, third and fourth textile layers 116,
120, and 124 are
not laminated and/or embedded within a polymeric layer.
[0096] In one embodiment, the needle stop patch 106 preferably includes a
fifth textile layer
128 having a plurality of interwoven threads 130A-130D that are laminated
and/or embedded
within a layer 132 of a polymeric material.
[0097] In one embodiment, the needle stop patch 106 is preferably
positioned over a posterior
wall of a shell of a prosthetic implant. In one embodiment, a bottom surface
134 of the fifth layer
128 of the needle stop patch 106 is preferably secured to an inner surface of
a posterior wall of a
shell of a prosthetic implant.
[0098] Referring to FIGS. 5 and 7, in one embodiment, a needle 135 having a
tapered distal
end 136 with a sharpened needle tip 138 may be inserted through the shell 102
of the prosthetic
implant 100 for filling the implant shell. If the sharpened needle tip 138 is
advanced too far toward
the posterior wall 105 of the shell 102, the sharpened needle tip 138 may
contact the needle stop
patch 106.
[0099] Referring to FIG. 7, in one embodiment, the multiple textile layer
construction of the
needle stop patch 106 preferably engages the tapered distal end 136 of the
needle 135 to apply
frictional forces on the side of the needle as the needle advances in the
direction DIR 1. The
multiple textile layers 112, 116, 120, 124, and 128 preferably have a specific
denier and thread
weave or geometries that "catch" the tapered distal end 136 and the needle tip
138 such that
force is not overly localized on the needle tip. In one embodiment, each
individual textile layer
112, 116, 120, 124, and 128 of the needle stop patch 106 is not impenetrable
on its own, however,
the cumulative effect of the multiple textile layer construction desirably
provides enough
resistance to prevent the needle from completely passing through the needle
stop patch 106
and/or piercing through the bottom surface 134 of the fifth textile layer 128
of the needle stop
patch 106.
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[00100] As used herein, Denier is a unit of linear mass density based on the
length and weight
of a thread or fiber. A single strand of silk is considered 1 denier, or more
specifically, a 9,000
meter long strand of silk is about 1 gram. For a given material, the higher
the denier count, the
greater the diameter of the thread or fiber. Or for a given diameter, the
higher the denier count,
the greater the density of the thread or fiber
[00101] In one embodiment, the denier count of the five layers 112, 116, 120,
124, and 128
may increase between the first layer 112 and the fifth layer 128 to
progressively increase the
resistance level fora needle passing through the needle stop patch 106.
[00102] Referring to FIG. 8, in one embodiment, a needle stop patch 206
preferably includes
a plurality of textile layers 212, 216, 220, and 224. In one embodiment, the
textile layers 212,
216, 220, and 224 have respective outer peripheral edges that define different
outer diameters.
In one embodiment, the outer peripheral edges of the textile layers are
feathered, or progressively
tapered, relative to one another to reduce a step affect and promote a gradual
stiffness gradient
between the respective textile layers 212, 216, 220, and 224. In one
embodiment, the first textile
layer 212 has outer diameter 0D1 that is greater than the outer diameter 0D2
of the second textile
layer 216. In turn, the second textile layer 216 has the second outer diameter
0D2 that is greater
than the third outer diameter 0D3 of the third textile layer 220. In turn, the
third textile layer 220
has the third outer diameter 0D3 that is greater than the fourth outer
diameter OD4 of the fourth
textile layer 224.
[00103] In one embodiment, the four textile layers 212, 216, 220, and 224 are
joined together.
In one embodiment, the four textile layers 212, 216, 220, and 224 are joined
together at the
respective outer peripheral edges thereof via a bonding material 240 that
extends through the
different textile layers. In one embodiment, the bonding material 240 may have
a ring shape that
extends adjacent the outer perimeter of the needle stop patch 206. In one
embodiment, central
regions of the textile layers 212, 216, 220, and 224 are not joined together,
which preferably
increases the flexibility of the needle stop patch 206 and minimizes the
stiffness of the needle
stop patch.
[00104] In one embodiment, the needle stop patch 206 may be secured to a wall
of a shell of
a prosthetic implant. In one embodiment, the '11' stop patch 206 may be
secured to an inner
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surface of a posterior wall 205 of a shell 202. In one embodiment, the bottom
surface 225 of the
fourth textile layer 224 is secured to the inner surface of the posterior wall
215 of the shell 202.
In one embodiment, the bonding material 240 may be used for securing the
needle stop patch
206 to a shell wall.
[00105] Referring to FIGS. 9A and 10A, in one embodiment, a first layer 212 of
a needle stop
patch 206 preferably has a top surface and the bottom surface 225. A first
ring 240A of a bonding
material may be assembled with the first textile layer 212. The first ring
240A of bonding material
may be centered on the first textile layer 212
[00106] Referring to FIGS. 9B and 10B, in one embodiment, the second textile
layer 216 is
positioned atop the first ring 240A of the bonding material, which extends
between a bottom
surface of the second textile layer 216 and the top surface of the first
textile layer 212. The second
textile layer 216 may be centered over the first textile layer 212. The area
of the first textile layer
212 is preferably greater than the area of the second textile layer 216.
(00107] Referring to FIGS. 9B and 10B, in one embodiment, a second ring 240B
of a bonding
material may be positioned atop the top surface of the second textile layer
216.
[00108] Referring to FIGS. 90 and 100, in one embodiment, the third layer 220
of the textile
material may be positioned atop the second ring 240B of bonding material that
extends between
a bottom surface of the third textile layer 220 and a top surface of the
second textile layer 216.
The third textile layer 220 may be centered over the second textile layer 216.
The area of the
second textile layer 216 is preferably greater than the area of the third
textile layer 220.
[00109] Referring to FIGS. 90 and 100, in one embodiment, a third ring 2400
of a bonding
material is positioned over the top surface of the third textile layer 220.
[00110] Referring to FIGS. 9D and 10D, in one embodiment, the fourth textile
layer 224 is
positioned atop the third ring 2400 of bonding material that extends between a
bottom surface of
the fourth textile layer 224 and a top surface of the third textile layer 220.
The fourth textile layer
224 may be centered over the third textile layer 220. The area of the third
textile layer 220 is
preferably greater than the area of the fourth textile layer 224.
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[00111 In one embodiment, the rings 240A, 240B and 2400 of the bonding
material preferably
have the same respective outer diameters and are preferably aligned with one
another for joining
the four textile layers 212, 216, 220, and 224 of the needle stop patch 206.
[00112] In one embodiment, the respective outer peripheries of the four
textile layers may be
compressed so that the bonding material within the bonding material rings
240A, 240B, 2400
flows through the woven threads of the respective textile layers for bonding
the textile layers
together adjacent the outer peripheries thereof. As noted above, in one
embodiment, only the
outer peripheries of the four textile layers 212, 216, 220, and 224 are bonded
together via the
rings 240A-2400 of the bonding material to enhance flexibility and/or reduce
the overall stiffness
of the needle stop patch 206. The flexibility of the needle stop patch 206
preferably enables the
patch and the shell that contains the patch to be folded during insertion into
a patient.
[00113] Referring to FIG. 11, in one embodiment, a needle stop patch 306
preferably includes
a textile layer 312 having a plurality of spaced holes 350A-350I extending
therethrough. In one
embodiment, the holes 350A-350I preferably enable fluid to communicate with an
inner lumen of
the shell when a filling needle bottoms out on the needle stop patch 306, even
in instances where
a textile layer may occlude a hole.
[00114] In one embodiment, each hole 350A-350I of the textile layer 312
desirably has an inner
diameter ID1 of about 0.1mm to 3mm. In one embodiment, the sum of the areas of
the holes
350A-350I is preferably greater than the outer diameter 005 of a filling
needle 336 that may
engage the textile layer 312 to prevent any bottlenecks and/or fluid
accumulation within the needle
stop patch 306. Designing a needle stop patch 306 so that the sum of the areas
of the holes
350A-350I formed in the textile layer 312 is greater than the outer diameter
0D5 of the needle
336, preferably avoids fluid accumulation within the one or more textile
layers, which prevents
localized accumulation of fluid within the needle stop patch. In one
embodiment, the holes
between the fibers naturally form as part of the woven, nonwoven, knit and
other patterns in
summation act as the fluid channels. In one embodiment, holes are further
created through the
textile via additional cutting or punching processes.
[00115] Referring to FIG. 12, in one embodiment, the needle stop patch 306
preferably
includes the first textile layer 312 having hol¨ and
a second textile layer 316 that may
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be joined with the first textile layer 312 using a methodology that is like
that shown and described
above in FIGS. 9A-9D and 10A-10D. In one embodiment, the second textile layer
316 preferably
includes holes 352A-352I extending therethrough. The holes 352A-352I of the
second textile
layer 316 are preferably offset from the holes 350A-350I of the first textile
layer 312 so that the
holes in the respective layers do not line up with one another when the first
and second textile
layers 312, 316 are assembled with one another.
[00116] FIG. 13 shows the first and second textile layers 312,316 assembled
with one another.
In one embodiment, the holes 350A, 3500 of the first textile layer 312 are not
in alignment with
the holes 352A, 3520 on the second textile layer 316. In FIG. 13 only central
regions of the first
and second textile layers 312, 316 are shown so that the outer peripheries of
the first and second
textile layers are not shown. In FIG. 13, all the holes shown in the first and
second layers in FIG.
12 are not shown in FIG. 13. FIG. 13 merely provides an example of how the
holes and the
respective layers 312, 316 are not in alignment with one another.
[00117] Referring to FIG. 14, in one embodiment, a needle stop patch 406
preferably has a
plurality of textile layers whereby the textile denier/weave and polymeric
material durometer may
progressively increase for each layer to provide a progressive stopping effect
on a needle tip that
is passed through the needle stop patch 406. In one embodiment, a top layer
324 has a
durometer that is lower than a first intermediate layer 320. In turn, the
first intermediate layer 320
has a lower durometer than a second intermediate layer 316. In turn, the
second intermediate
layer 316 has a lower durometer than the bottom layer 312. Thus, the
durometers of the
respective layers 324, 320, 316, and 312 progressively increase for each
successive layer from
the top layer 424 to the bottom layer 412 to provide a progressive stopping
effect on a needle tip
that engages and/or passes through the needle stop patch 406 in the direction
indicated DIR2.
[00118] In one embodiment, the respective layers 424, 420, 416, and 412
preferably have
different outer diameters so that the final assembly has feathered edges that
are designed to
reduce any step effects, thereby promoting gradual stiffness gradients.
[00119] In one embodiment, a bonding material 440 may be used for bonding the
layers 424,
420, 416, and 412 together. In one embodiment, the bonding material 440
preferably bonds only
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the outer peripheries of the respective layers to enhance flexibility and
reduce the overall stiffness
of the needle stop patch 406.
[00120] In one embodiment, adding additional textile layers to a needle stop
patch may
increase the needle penetration resistance that is provided by a needle stop
patch. For example,
a needle stop patch having five textile layers may provide more penetration
resistance than a
needle stop patch having four textile layers.
[00121] FIG. 15 is a graph which shows the increasing penetration resistance
as additional
textile layers are added to a needle stop patch. The graph plots different
types of textile layers
and how the penetration resistance is increased by adding additional layers to
a needle stop
patch.
[00122] In one embodiment, it may be desirable to maximize the flexibility of
a needle stop
patch by increasing the flexibility of the textile layers that are used to
make a needle stop patch.
Referring to FIG. 16, in one embodiment, a prior art testing system 550 may be
utilized for
evaluating the stiffness and/or flexibility of a textile layer. In one
embodiment, the testing system
550 preferably includes a horizontally extending surface 552 that is adapted
to support a fixed
end of a textile layer 512. The textile layer 512 desirably includes a hanging
end 515 that is not
supported by the support surface 552 so that the hanging end 515 is free to
flex downward into
an unsupported, open space. In one embodiment, the fixed end of the textile
layer 512 has a
length of about 0.25 inches and the hanging end 515 of the textile layer 512
has a hanging length
of about 2.75 inches. In one embodiment, the width of the textile layer 512
may be approximately
two (2) inches.
[00123] In one embodiment, it is desirable to increase penetration resistance
fora needle stop
patch with no significant loss of flexibility for the needle stop patch. FIG.
17 is a graph that shows
that different materials may be selected to maximize resistance to penetration
while providing no
significant loss of flexibility. In FIG. 17, a needle stop patch including
textile layers made of 0.015-
inch polyester are significantly more flexible than a needle stop patch
including textile layers made
of 0.027-inch polyester.
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[00124] While the foregoing is directed to embodiments of the present
invention, other and
further embodiments of the invention may be devised without departing from the
basic scope
thereof, which is only limited by the scope of the claims that follow. For
example, the present
invention contemplates that any of the features shown in any of the
embodiments described
herein, or incorporated by reference herein, may be incorporated with any of
the features shown
in any of the other embodiments described herein, or incorporated by reference
herein, and still
fall within the scope of the present invention.
